drugset / Trial / NCT01461785
The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer
RandomizedParallel-groupDouble-blindBasic science
Summary
In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of this study is to investigate the effect of the addition of PRP to the autologous fat transfer on local skin quality improvement, graft survival, and recovery after the procedure.
Timeline
- Start
- 2012-04
- Primary completion
- 2015-01
- Completion
- 2015-01
Publications
- Background Little JW. Applications of the classic dermal fat graft in primary and secondary facial rejuvenation. Plast Reconstr Surg. 2002 Feb;109(2):788-804. doi: 10.1097/00006534-200202000-00059.
- Background Coleman SR. Facial recontouring with lipostructure. Clin Plast Surg. 1997 Apr;24(2):347-67.
- Background Tzikas TL. Lipografting: autologous fat grafting for total facial rejuvenation. Facial Plast Surg. 2004 May;20(2):135-43. doi: 10.1055/s-2004-861754.
- Background Clauser L, Polito J, Mandrioli S, Tieghi R, Denes SA, Galie M. Structural fat grafting in complex reconstructive surgery. J Craniofac Surg. 2008 Jan;19(1):187-91. doi: 10.1097/scs.0b013e31815c94f5.
- Background Ducic Y, Pontius AT, Smith JE. Lipotransfer as an adjunct in head and neck reconstruction. Laryngoscope. 2003 Sep;113(9):1600-4. doi: 10.1097/00005537-200309000-00036.
- Background Jackson IT, Simman R, Tholen R, DiNick VD. A successful long-term method of fat grafting: recontouring of a large subcutaneous postradiation thigh defect with autologous fat transplantation. Aesthetic Plast Surg. 2001 May-Jun;25(3):165-9. doi: 10.1007/s002660010115.
- Background Conde-Green A, Baptista LS, de Amorin NF, de Oliveira ED, da Silva KR, Pedrosa Cda S, Borojevic R, Pitanguy I. Effects of centrifugation on cell composition and viability of aspirated adipose tissue processed for transplantation. Aesthet Surg J. 2010 Mar;30(2):249-55. doi: 10.1177/1090820X10369512.
- Background Erdim M, Tezel E, Numanoglu A, Sav A. The effects of the size of liposuction cannula on adipocyte survival and the optimum temperature for fat graft storage: an experimental study. J Plast Reconstr Aesthet Surg. 2009 Sep;62(9):1210-4. doi: 10.1016/j.bjps.2008.03.016. Epub 2008 Jun 20.
- Background Nguyen A, Pasyk KA, Bouvier TN, Hassett CA, Argenta LC. Comparative study of survival of autologous adipose tissue taken and transplanted by different techniques. Plast Reconstr Surg. 1990 Mar;85(3):378-86; discussion 387-9.
- Background Nishimura T, Hashimoto H, Nakanishi I, Furukawa M. Microvascular angiogenesis and apoptosis in the survival of free fat grafts. Laryngoscope. 2000 Aug;110(8):1333-8. doi: 10.1097/00005537-200008000-00021.
- Background Yamaguchi M, Matsumoto F, Bujo H, Shibasaki M, Takahashi K, Yoshimoto S, Ichinose M, Saito Y. Revascularization determines volume retention and gene expression by fat grafts in mice. Exp Biol Med (Maywood). 2005 Nov;230(10):742-8. doi: 10.1177/153537020523001007.
- Background Sommer B, Sattler G. Current concepts of fat graft survival: histology of aspirated adipose tissue and review of the literature. Dermatol Surg. 2000 Dec;26(12):1159-66.
- Background Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
- Background Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.
- Background Nikolidakis D, Jansen JA. The biology of platelet-rich plasma and its application in oral surgery: literature review. Tissue Eng Part B Rev. 2008 Sep;14(3):249-58. doi: 10.1089/ten.teb.2008.0062.
- Background Eppley BL, Pietrzak WS, Blanton M. Platelet-rich plasma: a review of biology and applications in plastic surgery. Plast Reconstr Surg. 2006 Nov;118(6):147e-159e. doi: 10.1097/01.prs.0000239606.92676.cf.
- Background Ferrara N, Gerber HP. The role of vascular endothelial growth factor in angiogenesis. Acta Haematol. 2001;106(4):148-56. doi: 10.1159/000046610.
- Background Nakamura S, Ishihara M, Takikawa M, Murakami K, Kishimoto S, Nakamura S, Yanagibayashi S, Kubo S, Yamamoto N, Kiyosawa T. Platelet-rich plasma (PRP) promotes survival of fat-grafts in rats. Ann Plast Surg. 2010 Jul;65(1):101-6. doi: 10.1097/SAP.0b013e3181b0273c.
- Background Ono S, Ogawa R, Hyakusoku H. Re: Use of Aquamid as a filler for facial rejuvenation in orientals. J Plast Reconstr Aesthet Surg 2009;62:1245-9. J Plast Reconstr Aesthet Surg. 2010 Jul;63(7):1227-8. doi: 10.1016/j.bjps.2009.12.008. Epub 2010 Jan 12. No abstract available.
- Background Salemi S, Rinaldi C, Manna F, Guarneri GF, Parodi PC. Reconstruction of lower leg skin ulcer with autologous adipose tissue and platelet-rich plasma. J Plast Reconstr Aesthet Surg. 2008 Dec;61(12):1565-7. doi: 10.1016/j.bjps.2008.04.048. Epub 2008 Aug 10. No abstract available.
- Background Lindeboom JA, Mathura KR, Aartman IH, Kroon FH, Milstein DM, Ince C. Influence of the application of platelet-enriched plasma in oral mucosal wound healing. Clin Oral Implants Res. 2007 Feb;18(1):133-9. doi: 10.1111/j.1600-0501.2006.01288.x.
- Background Shashikiran ND, Reddy VV, Yavagal CM, Zakirulla M. Applications of platelet-rich plasma (PRP) in contemporary pediatric dentistry. J Clin Pediatr Dent. 2006 Summer;30(4):283-6. doi: 10.17796/jcpd.30.4.8663xu2610324v36.
- Background Pietrzak WS, Eppley BL. Platelet rich plasma: biology and new technology. J Craniofac Surg. 2005 Nov;16(6):1043-54. doi: 10.1097/01.scs.0000186454.07097.bf.
- Background El-Sharkawy H, Kantarci A, Deady J, Hasturk H, Liu H, Alshahat M, Van Dyke TE. Platelet-rich plasma: growth factors and pro- and anti-inflammatory properties. J Periodontol. 2007 Apr;78(4):661-9. doi: 10.1902/jop.2007.060302.
- Background Wrotniak M, Bielecki T, Gazdzik TS. Current opinion about using the platelet-rich gel in orthopaedics and trauma surgery. Ortop Traumatol Rehabil. 2007 May-Jun;9(3):227-38. English, Polish.
- Background Mishra A, Woodall J Jr, Vieira A. Treatment of tendon and muscle using platelet-rich plasma. Clin Sports Med. 2009 Jan;28(1):113-25. doi: 10.1016/j.csm.2008.08.007.
- Background Bhanot S, Alex JC. Current applications of platelet gels in facial plastic surgery. Facial Plast Surg. 2002 Feb;18(1):27-33. doi: 10.1055/s-2002-19824.
- Background Henderson JL, Cupp CL, Ross EV, Shick PC, Keefe MA, Wester DC, Hannon T, McConnell D. The effects of autologous platelet gel on wound healing. Ear Nose Throat J. 2003 Aug;82(8):598-602.
- Background Redaelli A, Romano D, Marciano A. Face and neck revitalization with platelet-rich plasma (PRP): clinical outcome in a series of 23 consecutively treated patients. J Drugs Dermatol. 2010 May;9(5):466-72.
- Background Engebretsen L, Steffen K, Alsousou J, Anitua E, Bachl N, Devilee R, Everts P, Hamilton B, Huard J, Jenoure P, Kelberine F, Kon E, Maffulli N, Matheson G, Mei-Dan O, Menetrey J, Philippon M, Randelli P, Schamasch P, Schwellnus M, Vernec A, Verrall G. IOC consensus paper on the use of platelet-rich plasma in sports medicine. Br J Sports Med. 2010 Dec;44(15):1072-81. doi: 10.1136/bjsm.2010.079822. No abstract available.
- Background Wang-Saegusa A, Cugat R, Ares O, Seijas R, Cusco X, Garcia-Balletbo M. Infiltration of plasma rich in growth factors for osteoarthritis of the knee short-term effects on function and quality of life. Arch Orthop Trauma Surg. 2011 Mar;131(3):311-7. doi: 10.1007/s00402-010-1167-3. Epub 2010 Aug 17.
- Background Donofrio LM. Panfacial volume restoration with fat. Dermatol Surg. 2005 Nov;31(11 Pt 2):1496-505. doi: 10.2310/6350.2005.31234.
- Background Eremia S, Newman N. Long-term follow-up after autologous fat grafting: analysis of results from 116 patients followed at least 12 months after receiving the last of a minimum of two treatments. Dermatol Surg. 2000 Dec;26(12):1150-8.
- Background Ersek RA. Transplantation of purified autologous fat: a 3-year follow-up is disappointing. Plast Reconstr Surg. 1991 Feb;87(2):219-27; discussion 228.
- Background Brucker M, Sati S, Spangenberger A, Weinzweig J. Long-term fate of transplanted autologous fat in a novel rabbit facial model. Plast Reconstr Surg. 2008 Sep;122(3):749-754. doi: 10.1097/PRS.0b013e3181815a41.
- Background Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
- Background Tischler M. Platelet rich plasma. The use of autologous growth factors to enhance bone and soft tissue grafts. N Y State Dent J. 2002 Mar;68(3):22-4.
- Background Strem BM, Hicok KC, Zhu M, Wulur I, Alfonso Z, Schreiber RE, Fraser JK, Hedrick MH. Multipotential differentiation of adipose tissue-derived stem cells. Keio J Med. 2005 Sep;54(3):132-41. doi: 10.2302/kjm.54.132.
- Background Gimble J, Guilak F. Adipose-derived adult stem cells: isolation, characterization, and differentiation potential. Cytotherapy. 2003;5(5):362-9. doi: 10.1080/14653240310003026.
- Background Madonna R, Geng YJ, De Caterina R. Adipose tissue-derived stem cells: characterization and potential for cardiovascular repair. Arterioscler Thromb Vasc Biol. 2009 Nov;29(11):1723-9. doi: 10.1161/ATVBAHA.109.187179. Epub 2009 Jul 23.
- Background Kim JH, Jung M, Kim HS, Kim YM, Choi EH. Adipose-derived stem cells as a new therapeutic modality for ageing skin. Exp Dermatol. 2011 May;20(5):383-7. doi: 10.1111/j.1600-0625.2010.01221.x. Epub 2011 Feb 28.
- Background Pallua N, Wolter T, Markowicz M. Platelet-rich plasma in burns. Burns. 2010 Feb;36(1):4-8. doi: 10.1016/j.burns.2009.05.002. Epub 2009 Jun 21.
- Background Strasser EJ. Application of an objective grading system for the evaluation of cosmetic surgical results. Plast Reconstr Surg. 2002 Apr 15;109(5):1733-40. doi: 10.1097/00006534-200204150-00042. No abstract available.
- Background Pusic AL, Klassen AF, Scott AM, Cano SJ. Discussion. The measure of face-lift patient satisfaction: the Owsley Facelift Satisfaction Survey with a long-term follow-up study. Plast Reconstr Surg. 2010 Jul;126(1):258-260. doi: 10.1097/PRS.0b013e3181dbba19. No abstract available.
- Background Nedelec B, Correa JA, Rachelska G, Armour A, LaSalle L. Quantitative measurement of hypertrophic scar: interrater reliability and concurrent validity. J Burn Care Res. 2008 May-Jun;29(3):501-11. doi: 10.1097/BCR.0b013e3181710881.
- Background Draaijers LJ, Botman YA, Tempelman FR, Kreis RW, Middelkoop E, van Zuijlen PP. Skin elasticity meter or subjective evaluation in scars: a reliability assessment. Burns. 2004 Mar;30(2):109-14. doi: 10.1016/j.burns.2003.09.003.
- Background Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x.
- Background Ezure T, Hosoi J, Amano S, Tsuchiya T. Sagging of the cheek is related to skin elasticity, fat mass and mimetic muscle function. Skin Res Technol. 2009 Aug;15(3):299-305. doi: 10.1111/j.1600-0846.2009.00364.x.
- Background Tronnier H, Wiebusch M, Heinrich U. Change in skin physiological parameters in space--report on and results of the first study on man. Skin Pharmacol Physiol. 2008;21(5):283-92. doi: 10.1159/000148045. Epub 2008 Jul 28.
- Background Yamaguchi R, Terashima H, Yoneyama S, Tadano S, Ohkohchi N. Effects of platelet-rich plasma on intestinal anastomotic healing in rats: PRP concentration is a key factor. J Surg Res. 2012 Apr;173(2):258-66. doi: 10.1016/j.jss.2010.10.001. Epub 2010 Nov 2.
- Background Krupski WC, Reilly LM, Perez S, Moss KM, Crombleholme PA, Rapp JH. A prospective randomized trial of autologous platelet-derived wound healing factors for treatment of chronic nonhealing wounds: a preliminary report. J Vasc Surg. 1991 Oct;14(4):526-32; discussion 532-6.
- Background Silva A, Sampaio R. Anatomic ACL reconstruction: does the platelet-rich plasma accelerate tendon healing? Knee Surg Sports Traumatol Arthrosc. 2009 Jun;17(6):676-82. doi: 10.1007/s00167-009-0762-8. Epub 2009 Mar 14.
- Background de Jonge S, de Vos RJ, Van Schie HT, Verhaar JA, Weir A, Tol JL. One-year follow-up of a randomised controlled trial on added splinting to eccentric exercises in chronic midportion Achilles tendinopathy. Br J Sports Med. 2010 Jul;44(9):673-7. doi: 10.1136/bjsm.2008.052142. Epub 2008 Oct 6.
- Background Dogramaci Y, Kalaci A, Savas N, Duman IG, Yanat AN. Treatment of lateral epicondilitis using three different local injection modalities: a randomized prospective clinical trial. Arch Orthop Trauma Surg. 2009 Oct;129(10):1409-14. doi: 10.1007/s00402-009-0832-x. Epub 2009 Feb 14.
- Background Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
- Background Martinez-Zapata MJ, Marti-Carvajal A, Sola I, Bolibar I, Angel Exposito J, Rodriguez L, Garcia J. Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Transfusion. 2009 Jan;49(1):44-56. doi: 10.1111/j.1537-2995.2008.01945.x. Epub 2008 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Platelet Rich Plasma | Other / unclassified | 3 ml | — |
Indications
No indication recorded.